Generic Taxotere Lawsuits Allowed in Federal MDL

The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) has allowed claims involving generic docetaxel, a chemotherapy drug, to be included in the Taxotere MDL now underway in the Eastern District of Louisiana.

Judge Sarah S. Vance, Chair of the JPMDL, stated in a letter that the consolidated litigation does include lawsuits against both name-brand and generic forms of the drug.

The panel’s letter was in response to District Judge Kurt D. Engelhardt, who wrote to the panel for clarification in December. Judge Engelhardt is overseeing 1,006 lawsuits filed in 2740, IN RE: Taxotere (Docetaxel) Products Liability Litigation.

Half of cases against generics

Taxotere, manufactured by Sanofi, lost its patent protection in late 2010. Half of the cases in the MDL involve generic and quasi-generic manufacturers, whose products obtained FDA approval under 21 USC Sec. 505(b)(2) and not through the more traditional generic approval under 21 USC Sec. 505(j).

The plaintiffs charge that they experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy.

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

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Taxotere Judge Sets Science Day

US District Judge Kurt D. Engelhardt ordered the parties in Taxotere litigation in MDL 2740, where 949 cases are filed in the Eastern District of Louisiana, charging that the chemotherapy drug caused disfiguring, permanent and total hair loss among patients.

Defendants include Sanofi S.A., Aventis Pharma S.A., Sanofi US Services Inc. f/k/a Sanofi-Aventis U.S. Inc., and Sanofi-Aventis U.S. LLC.

“Science Days” have become a tradition in mass tort litigation. In the last few years, there is a Science Day somewhere, in some courtroom, going on.  Trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them.

Taxotere and Hair Loss

A total of 799 Taxotere lawsuits have been filed by plaintiffs who experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

In other orders, the judge:

  • Scheduled a follow-up meeting with the settlement committees on May 12, 2017, after the conclusion of the general status conference scheduled for this date.
  • Approved an exemplar Short Form Complaint to use when filing new cases.

The plaintiffs’ Plaintiffs’ Co-Liaison Counsel are:

  • Dawn M. Barrios of Barrios, Kingsdorf & Casteix, New Orleans, LA.
  • Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, New Orleans, LA.

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Crusading Judge Takes Over Taxotere Products Liability Litigation

Chief Judge Kurt Engelhardt
Chief Judge Kurt D. Engelhardt

Judge Kurt D. Engelhardt, who courageously investigated the New Orleans US Attorney’s Office for misconduct in a police murder prosecution, will apply his no-nonsense approach to dozens of mass tort lawsuits against Sanofi S.A. over its chemotherapy drug, Taxotere.

Judge Engelhardt, age 56, has been on the federal bench for 15 years and ascended to Chief Judge in the US Eastern District of Louisiana in New Orleans in 2015. Previously he has supervised two product liability MDLs:

  • Franck’s Lab. Inc. Product Liability Litigation MDL 2454, which was closed on May 21, 2016, when all the parties settled. The MDL was created in 2013. The lab compounded pharmaceutical products that were contaminated by fungus and toxins, which caused rare eye infections and blindness.
  • FEMA Trailer Products Liability Litigation MDL 1873, which was closed on October 26, 2015, after three waves of settlements. Companies that manufactured mobile homes for the Federal Emergency Management Agency after Hurricane Katrina agreed to pay $2.6 million to resolve claims that the mobile homes emitted formaldehyde

Engelhardt will supervise the new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation consisting of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

The plaintiffs charge that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not. The lawsuits allege that Sanofi was aware of this possible side effect and failed to warn patients, and that the defendants marketed Taxotere as more effective than similar drugs when other drugs were equally effective without causing permanent hair loss.

“Grotesque Misconduct” in Federal Prosecution

A notorious criminal trial in New Orleans illustrates the importance that the judge places on the integrity of the courts. From 2012-2013 Judge Engelhardt investigated gross misconduct in the US Attorney’s office in New Orleans in its prosecution of five policemen who were charged in the 2005 killing of two people and injury of four others on the Danziger Bridge after Hurricane Katrina. The cops were convicted of civil rights and other charges in 2011.

The judge threw out the convictions in 2013 after determining that three federal prosecutors improperly attacked the judge, the police and defense lawyers in anonymous online postings, and leaked confidential information. Two investigations by the US Attorney’s office — one led by a guilty prosecutor — were cover-ups of “grotesque prosecutorial misconduct,” according to the judge.

“The public must have absolute trust and confidence in this process,” Engelhardt wrote in overturning the verdicts. “Re-trying this case is a very small price to pay in order to protect the validity of the verdict in this case, the institutional integrity of this court and the criminal justice system as a whole.”

The 5th Circuit upheld Judge Engelhardt’s decision in 2015, and the case finally ended on April 20, 2016, when the five Danziger Bridge cops pleaded guilty.

The Fifth Circuit ruled that the prosecutors’ “insidious” cyberbullying created a mob mentality against the defendants. “[p]rejudice here was shown both from this pattern of misconduct and evasion and from other abusive prosecutor actions,” it said. “A miscarriage of justice harms the substantial rights of a defendant, and it may consist of errors and omissions considered for their cumulative effect on the trial proceedings.”

Judge Engelhardt’s skepticism of the Department of Justice was also highlighted in the three-year sentence he imposed on a corrupt local prosecutor, St. Charles Parish District Attorney Harry Morel Jr. An FBI agent had sent the judge a 31-page letter about ethical lapses in the Justice Department. Engelhardt refused to release the letter but said it was “particularly interesting (and troubling, to say the least).”

The Justice department had ended an investigation into serious allegations that he traded leniency in court for sex from defendants, but let him plead guilty to obstruction of justice. Judge Engelhardt gave Morel the maximum sentence allowed.

Recently he sentenced once-fugitive real estate financier Robert Durst to 7 years and 1 month on a weapons charge that cleared the path for him to face murder charges in California. Durst will serve more than 4 ½ times the maximum under federal guidelines based on a plea deal with prosecutors in Houston, Manhattan and Orleans Parish not to prosecute him on a variety of offenses.

Cited for excellence

As an MDL judge, Engelhardt can be expected to be an efficient stickler for deadlines and details. In 2004 he was appointed by US Supreme Court Chief Justice Rehnquist to serve on the Judicial Conference Committee on Federal-State Jurisdiction, where he served two terms, which may be beneficial in the MDL case management. His work on the Judiciary Commission has been cited for its excellence by the Louisiana Supreme Court.

On the bench, had actually has few criminal case opinions. Most of his rulings focus on insurance coverage disputes, contract actions, legal malpractice and immigration.

In the 2,059 opinions that he’s written since 2002, Judge Engelhardt cites frequently to the 5th Circuit, and often relies on deposition and trial testimony to support his decisions. He writes matter-of-fact and direct opinions and doesn’t stray from the issues of the case.

In scheduling order dates, he does not permit waivers from the dates absent substantive notice to the court by timely motion.

In personal injury cases, he tends to rule in favor of summary judgment defendants where there is any question as to causation or future damages for injuries. In personal injury cases where remand is requested, prior settlement language as to co-defendants is strictly interpreted as to who remains in the case.

Prior to becoming a judge he handled commercial litigation disputes over contracts and insurance coverage disputes. He practiced at Hailey, McNamara, Hall, Larrman & Papale, an insurance defense firm in Metarie, LA. 

The Hailey firm does not appear to have been involved in representing any pharma or drug device clients, there is a brief reference to products liability defense work in the practice summary, but no cases listed to date.

 

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New MDLs Consolidate Cases for Abilify, Roundup, Talc and Taxotere

Consolidating thousands of lawsuits involving Abilify schizophrenia drug, Roundup herbicide, Talc powder and Taxotere cancer drug, US Judicial Panel on Multidistrict Litigation (JPML) in Washington, DC, created new multidistrict litigation (MDL) dockets for the mass tort cases.

This is good news for plaintiffs. In due course the assigned courts will create short-form complaints and plaintiff fact sheets, facilitating the filing of new actions. Each litigation will be led by a plaintiff’s steering committee appointed by the judge, who will set a discovery schedule and select representative cases for bellwether trials.

abilifyAbilify (Aripiprazole)

Responding to a motion from all the parties, the JPML created new MDL 2734, In re: Abilify Products Liability Litigation, supervised by US District Judge M. Casey Rodgers in the Northern District of Florida. The ruling consolidates 22 actions filed in 12 district courts against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

WHO-says-Roundup-probably-causes-cancerRoundup (Glyphosate)

Granting the plaintiffs’ motion, the JPML created the new MDL No. 2741, In Re: Roundup Products Liability Litigation, supervised by Judge US District Vince Chhabria in the Northern District of California. Monsanto opposed consolidation. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in twenty-one districts. More than ten different law firms represent plaintiffs in these actions, which are spread across the country.

These actions share common factual questions arising out of allegations that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma. Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

talc johnson & johnsonTalcum Powder

The JPML created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

The plaintiffs allege that they or their decedents developed ovarian or uterine cancer following perineal application of Johnson & Johnson’s talcum powder products (namely, Johnson’s Baby Powder and Shower to Shower body powder). Two of the actions are consumer class actions brought on behalf of putative classes of women who allege that defendants deceptively marketed the talcum powder products for feminine hygienic use without disclosing talc’s carcinogenic properties. All the actions involve factual questions relating to the risk of cancer posed by talc and talc-based body powders, whether the defendants knew or should have known of this alleged risk, and whether defendants provided adequate instructions and warnings with respect to the products.

For more information read Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

taxotere hair lossTaxotere (Docetaxel)

The JPML created new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation, supervised by Chief US District Judge Chief Judge Kurt Engelhardt in the Eastern District of Louisiana. The litigation consists of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

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